Effect of estradiol vaginal gel on vaginal atrophy in postmenopausal women: A randomized double-blind controlled trial
ประสงค์ ตันมหาสมุทร*, Titima Jirasawas, Somsak Laiwejpithaya, Chatchai Areeswate, Chongdee Dangrat, Kittayaporn Silprasit
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok 10700, Thailand; Email: prasong.tan@mahidol.ac.th
Aim: To evaluate the efficacy and safety of 25 μg of estradiol gel on postmenopausal vaginal tissue.
Methods: This randomized double-blind controlled trial included postmenopausal women with vaginal atrophy who attended our menopause clinic during July 2017-January 2018. Women were randomly assigned to the estradiol gel group or control group (K-Y® Jelly). Treatment consisted of 2 mL of product applied intravaginally daily for 2 weeks, and two doses per week for the next 6 weeks. The most bothersome symptom (MBS), vaginal health index (VHI), vaginal pH, vaginal maturation index, vaginal maturation value (VMV), female sexual function index (FSFI), serum estradiol level and endometrial thickness were evaluated at baseline, 4 and 8 weeks.
Results: Seventy-five of 80 women completed the trial. After 8 weeks of treatment, VMV, VHI, vaginal pH and FSFI improved significantly in the estradiol group, with no observed change in the control group. The MBS was decreased in both groups with no significant difference between groups. Serum estradiol level and endometrial thickness were not significantly different between groups at baseline or at week 8.
Conclusion: Estradiol vaginal gel demonstrated an ability to reverse vaginal atrophy with a high safety profile and low systemic absorption of estradiol.
Journal of Obstetrics and Gynaecology Research ปี 2563, August ปีที่: 46 ฉบับที่ 8 หน้า 1425-1435
Postmenopausal women, estradiol vaginal gel, vaginal atrophy